OSD

Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature

Product code
OSD
Device name
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
Device class
Class 2
21 CFR
21 CFR 890.5670
Medical specialty
Physical Medicine
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification definition

Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-07-27.

NumberDecision dateApplicantDevice nameSummary
K2504192026-07-27Plus EV Holdings, Inc. D/B/A Intimate …Intimate Rose Pelvic Wand (Purple); Intimate Rose Be…FDA
Official FDA classification page: OSD
Classification and pathway per current FDA publications. Data from openFDA (CC0).